Catheter with cuff inflater and indicator



Oct. 29,1968 E. A. GALLEHER, JR 3,407,817

CATHETER WITH CUFF INFLATER AND INDICATOR Filed July 26, 1965 INVENTOR.

ELLIS A. GALLEHER JR. BY

ATTORNEY.

United States Patent 3,407,817 CATHETER WITH CUFF INFLATER AND INDICATOR Ellis A. Galleher, Jr., Sarasota, Fla., assignor, by mesne assignments, to Air Reduction Incorporated, a corporation of New York Filed July 26, 1965, Ser. No. 474,807 4 Claims. (Cl. 128-351) ABSTRACT OF THE DISCLOSURE A catheter with a manually inflatable cuff, said catheter comprising a tube having a main bore opening through the ends of the tube and a longitudinally extending passage in the wall of the tube, said passage being plugged adjacent one end of said tube and communicating with the cuff through said wall to inflate said cuff, cuff inflating means inserted in said passage at the other end of said tube, said means including a check valve, a hand pressure bulb, and a pressure indicating member, said member indicating the extent to which the cuff is inflated by means of said hand pressure bulb and having means associated therewith for simultaneously deflating the cuff and indicating member.

My invention relates to catheter constructions such as those of the endotracheal type and relates more particularly to a catheter having means associated with, and as a component part of, the construction for manually inflating the catheter cuff and simultaneously visually indicating the degree to which the cuff is being inflated.

Another object of the invention is a catheter having an inflatable cuff of low modulus having high resistance to ozone, oxygen, heat and normal hospital chemicals such as anesthetic agents and ordinary cold sterilants at room temperatures, and which is orally inflatable at low pressures.

Another object is a catheter construction which readily lends itself to economical production, which is substantially of the same outside diameter throughout its length when the cuff is deflated, and which is provided with an internal independent passage or duct formed within the Wall of the catheter and communicating with the cuff and a combined inflater and inflation indicator.

A further object is a novel cuff inflater and pressure indicator means for connection with a passage or duct in the catheter tube leading to the cuff and which is readily removably applied to the end of the catheter remote from the cuff.

Still another object is to provide means for inflating the catheter cuff by the application of successive low pressure cumulative impulses up to a desired inflation pressure in the cuff and to visually indicate step by step the accumulated inflated condition of the cuff.

Another object is to prevent overinflation of the cuff and serious damage to membranes when the cuff is hidden from view as in a body cavity when in use.

Another object is to provide means to quickly deflate the cuff and indicator when desired, as in removing the catheter from the body cavity or in the event of emergency.

Other objects and advantages of this invention will become more apparent as the following description of an embodiment thereof progresses, reference being made to the accompanying drawing in which like reference characters are employed to designate like parts throughout the same.

In the drawings:

FIGURE 1 is a side elevation of a catheter of the endotracheal type showing the cuff and inflation indicator in 3,407,817, Patented Oct. 29, 1968 solid lines when deflated and illustrating the same in broken lines when inflated;

FIGURE 2 is a transverse section taken on line 22 of FlGURE 3;

FIGURE 3 is a longitudinally distended view of the catheter illustrated in FIGURE 1 and is broken away in part in vertical section to clearly show the passage or duct formed in the catheter tube wall and the manner in which the inflater and inflation indicator device is assembled on the remote end of the catheter tube. In this view the cuff is shown as only slightly inflated;

FIGURE 4 is a vertical enlarged section through the inflater device;

FIGURE 5 is a side elevation of a modified form of the inflater-indicator means; and

FIGURE 6 is a transverse section similar to that taken on line 22 of FIGURE 3 but illustrates a modified wall structure surrounding the inflation passage.

Referring now more particulary to the accompanying drawing which illustrates one general form of my invention, the catheter tube is indicated at 10, and, as illustrated in FIGURE 6, preferably employs a tube of suitable flexible material such as rubber, rubber compounds, or other plastic compositions, the wall defining the tube being of substantially uniform thickness in cross section throughout the length of the tube.

The annular tube wall 40 is of uniform thickness and its bore 41 is concentric with the outer smooth surface 10. The passage 16 formed longitudinally within the wall 40 is surrounded with a wall thickness not substantially greater than that at 40, since the thickness of the wall material on diametrically opposed sides of the passage 16, as at 42 and 43, and radial with respect to the longitudinal axis of the bore 41 is substantially one-half the thickness of the tube wall at other points around the tube.

A slightly modified form of catheter tube is shown in section in FIGURE 2 in which the wall defining the bore 13 of the tube can be eccentric to the true central axis of the tube. Both tubes terminate at one end in a bevelled round pointed nose portion 11, there being an opening 12 near the bevelled nose of the tube for reciprocal passage of material from the main bore 13 into the organ or cavity with which it communicates.

The catheter tube formed as in FIGURE 2 provides a thicker tube wall portion 14 adjacent one side of the bore 13 and a relatively narrow portion 15 diametrically opposite 14. It is through this thicker wall 14 that the passage or duct 16 is formed. Since the passage, when so formed, will extend throughout the length of the tube, and since the purpose of this passage is to conduct fluid pressure to the inflatable cuff 17, it must be plugged up and sealed, as at 18, from the nose portion of the catheter tube to a point underlying the cuff. A branch or transverse passage 19 then is formed through the wall 14 and communicates with the interior of the cuff and the passage 16, as shown in FIGURE 3.

When the catheter tube is first formed an in FIGURES 2 and 6, nosed as at 11, the opening 12 formed, and the section of the passage 16 plugged up at 18, but before the cuff is assembled on the tube, the tube is preferably dipped in a film forming solvent solution of a material compatiible with the material of the tube, i.e., having the same properties as that of the tube material whereby to coat the inner surface of the bore 13 and the outer surface of the tube. The inflatable cuff, which is preferably a thin walled rubber sleeve of low modulus and having high resistance to ozone, oxygen, heat and normal hospital chemicals such as anesthetic agents and ordinary sterilants at room temperatures, is then snugly telescoped over the tube end and adjusted to overlie at its midpoint, the branch passage 19. The uninfiated sleeve snugly fits the tube and lies smoothly and unwrinkled thereagainst. In

3 this position, the cuff is then bonded to the catheter tube by brushing or otherwise applying a compatible cement to the tube and the opposite ends of the cuff while turning the tube, as indicated at 20.

As a material part of this invention as applied to tubes having cross sectional walls of either FIGURE 2 or FIG- URE 6, I provide means for insertion into an end of the passage 16 for inflating the cuff and for observing the degree to which the cuff is inflated. Such means preferably consists of thumb and finger actuated pump, a check valve, a pressure indicator and a pressure release for deflating the cuff quickly.

As shown, one form of check valve included in such means may be a body comprising a hollow casing 21 terminating at one end in a passage 22 of considerably reduced diameter and bore and preferably extending laterally of the body. The passage 22 terminates in a tapered open end or nose 23 for easy insertion into the open end of the passage 16 at one end of the catheter tube as shown in FIGURE 3.

The valve body or casing is also formed with a boss 24 having an opening 25 through its end wall and is provided with an external bead 26 about its periphery.

The casing 21 is open at its lower end to receive a check valve unit 27 which is provided at its bottom end with an annular flange 28 overlying the annular external bead 29 of the casing open end, whereby to permit the unit to be inserted to its full length terminating at its upper end below the boss 24. An O-ring packing 30 is carried in an annular groove in the unit 27 and seals against the internal wall of the casing 21 preventing leakage of pressure below the ring.

A compressible bulb 31 is fitted at its open end over the flange 28, and bead 29, and the lower external wall of the casing 21, as shown in FIGURE 4, and is provided with an air inlet opening 32 to the atmosphere when it is uncovered by the finger of the operator.

In the form shown, the check valve unit is provided with a duct or passage 33 communicating at one end with the bulb 31 and opens laterally at its other end toward the space 34, as at 33. A resilient band 35 of thin rubber encircles the upper portion of the unit and overlies and normally closes the opening 33', but when the bulb 31 is depressed with the finger and thumb of the operator closing the opening 32, air under compression within the bulb will unseat the band and allow the air pressure to enter the space 34 and pass around the upper end 36 of the valve unit 27 and into the upper chamber 37 of the housing, through the tube 22 and into the passage 16, 19 and thence to the interior of the cuff 17. At the same time fluid pressure will :be delivered through the opening 25 and into a pressure indicator tube 38 having a normally preset coiled or helical form. The indicator is telescoped at its open end over the boss 24 as shown, and responds with the cuff to each pressure pulse upon compression of the bulb 31, by a progressive unwinding of the coil, as illustrated in broken lines in FIGURE 1. As the pressure builds up in inflating the cuff, it will proportionately uncoil the pressure indicator tube 38, clearly and visually indicating to the operator the degree of inflation of the cuff which, of course, when inserted into the trachea or other body cavity, is hidden from view.

Thus, when the cuff is inflated to the desired extent, as indicated by the pressure indicator, the accumulated pressure in the cuff and indicator can be released quickly by lifting the tab or skirt 39 upwardly and pulling it outwardly of the boss sufficiently to exhaust the pressure in the entire line to the outside atmosphere through the opening 25 and past the raised tab 39 and the head 26. With back pressure on the band 35 while the cuff and pressure indicator tube are inflated, the opening 33' remains closed and consequently there will be no release of pressure through the bulb 31.

With reference to FIGURE 5, it will be observed that the structure is substantially the same as the corresponding inflating means shown in FIGURE 3 except that the tab 39' extends around the casing 21 beyond a point corresponding to the terminal end of the tab 39 and terminates in a lip 39" extending radially from the casing to provide easy access for the user to firmly grip the lip to raise the tab 39 from the opening 25 to exhaust pressure therethrough from the passage 16 and the cuff 17.

It is to be understood that while a catheter tube having a cross section such as is illustrated in FIGURE 6, that is, in which the thickness of the material forming tube wall 40 is substantially uniform throughout, whereas that illustrated in section in FIGURE 2 is thicker in the area of the passage 16 and progressively thinner to a diametrically opposed area, it is intended that either form shall be employed in the overall invention as disclosed herein.

In this form (FIGURE 6), the tube wall 40 is of uniform thickness throughout its transverse cross-sections, it being understood that the sum of the thickness of the wall portions 42 and 43 on both sides of the passage 16 in a direction radial to the longitudinal axis of the tube 10 is substantially equal to the thickness of the wall 40 in other radial directions through the tube. Thus the tube bore 41 is concentric to the major area of the outer wall of the tube as distinguished from the eccentric relationship of these corresponding parts as shown in FIGURE 2.

From the above, it will be understood that by my novel invention, the possibility of producing trauma in the patient due to overinflation of the cuff is substantially eliminated and that, in other respects, such as the smooth unobstructed exterior surfaces of the catheter and deflated cuff, the safety factor in its use is materially increased over those catheters of which I am aware are now in general use.

Various changes may be made in the details of construction and arrangement of parts of the invention without departing from the spirit thereof or the scope of the appended claims.

I claim:

1. A catheter comprising a tube of elongated configuration adapted to be inserted in a body passageway and having a main bore opening through the ends of the tube, a through-passage extending longitudinally within the wall of the tube and having plug means inserted therein adjacent one end of said tube to seal said passage, an inflatable cuff encircling the tube at a position near said one end of the tube, said tube passage having communication through the wall of the tube adjacent said plug means with the interior of the inflatable cuff, cuff inflating means inserted in the passage near the opposite end of the tube, said inflating means having a pressure release opening therein, resilient means removably secured over said opening in sealing relation thereto, said resilient means in said sealing relation indicating the extent to which said cuff is inflated in response to fluid pressure from said inflating means, and said resilient means when removed from said sealing relation simultaneously deflating itself and said cuff.

2. A catheter comprising a tube of elongated configuration adapted to be inserted in a body passageway and having a main bore opening through the ends of the tube, a passage formed longitudinally of the tube within the wall of the tube, an inflatable cuff encircling the tube at a position near one open end of the tube, said passage having communication through the wall of the tube with the interior of the inflatable cuff, cuff inflating means inserted in the passage near the opposite end of the tube, said inflating means having a pressure release opening therein, resilient means removably secured over said opening in sealing relation thereto, said resilient means in said sealing relation indicating the extent to which said cuff is inflated in response to fluid pressure from said inflating means, and said resilient means when removed from said sealing relation simultaneously deflating itself and said cuff.

3. A catheter comprising a tubular structure of elongated configuration adapted to be inserted in a body passageway and having a main bore opening through the ends of the tube, a passage formed longitudinally of the tube within the wall of the tube, an inflatable cuff encircling the tube at a position near one open end of the tube, said passage having communication through the wall of the tube with the interior of the inflatable cuff, cuff inflating means inserted in the passage near the opposite end of the tube, resilient means responsive to fluid pressure in the passage and cufl for indicating the state of inflation of the cuff, said cufl inflating means comprising a valve casing, a check valve in the casing, a hand pressure bulb for delivering fluid pressure in successive impulses through the valve in one direction to the cuff and to said indicating means simultaneously for building up the inflation of the cult and indicating the extent to which the cufl is inflated, and means associated with said resilient means for simultaneously deflating the cuff and resilient means.

4. An endotracheal catheter and pressure indicating structure comprising a catheter tube of elongated configuration for insertion in the trachea, a passage formed within the tube wall and extending from the distal end of the tube to a portion underlying an inflatable catheter cufl, said cufl encircling the tube and having communication with the passage, means inserted in the distal end of the passage for inflating the cuff and indicating the degree of inflation thereof and comprising a hand pressure bulb having an opening communicating with the atmosphere, a check valve within said means, said valve having at least one passageway communicating between said bulb and a point adjacent the distal end of said tube, and an elastic element overlying said passageway in sealing relation thereto said point, said bulb on compression moving said element to permit flow of fluid from within the bulb to the distal end of said tube into said passage, a boss 011 said means adjacent said distal end and having a bore therethrough communicating with the interior of said means adjacent said point, a pressure indicating member fitted over said boss, said indicating member being cumulatively responsive to each of a succession of pressure impulses generated each time the bulb is compressed while its said opening is closed, said indicating member including a flexible tube having a preset. coiled configuration when dormant, but in which, under the influence of said fluid pressure, the configuration is progressively varied as the applied fluid pressure is increased.

References Cited UNITED STATES PATENTS 923,303 6/1909 Shults 128-344 2,845,930 8/ 1958 Brown 128-348 2,933,570 4/ 1960 Tutthill. 2,936,761 5/1960 Snyder 128-349 3,049,125 8/ 1962 Kriwkowitsch 128-325 3,081,773 3/1963 Isaac. 3,193,183 7/1965 Ruhala et al. 3,211,150 10/1965 Foderick 128-349 3,232,116 2/ 1966 Perkins 73-418 2,701,559 2/ 1955 Cooper. 2,930,377 3/1960 Cowley 128-344 FOREIGN PATENTS 693,510 7/ 3 Great Britain.

158,397 2/1963 Russia.

151,721 6/1953 Australia.

DALTON L. TRULUCK, Primary Examiner. 

